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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE

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PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
The clinical complaint is in the process of investigation. The lot number has not been verified due to the absence of information. It will be confirmed whether any clinical complaints have been found for the particular lot number in question once requested information is provided. The batch record, qc test reports, and training of staff will be analysed and be determined that product is within required specifications, and manufactured according to appropriate procedures once lot is verified. Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic along with the letter indicating approved areas for injection for revanesse versa+ and revanesse lips+ products when requested information for conducting investigation is provided.
 
Event Description
Based on the information provided, the patient got injected with revanesse dermal fillers in the lips area of the patient on (b)(6) 2022. The lot of the product injected was not provided and, therefore, not verified. Amount of product injected was not specified. Patient is a female; date of birth not provided. According to the initial communication, the patient has called and come back in for evaluation on a couple occasions since initial procedure because the patient was having pain/discomfort still at the injection site. Patient was seen (b)(6) 2022 and had another appointment on (b)(6) 2022 with the clinic for a dissolving procedure. In addition, the patient was not pleased with some pulling she is having which is noticeable especially when she smiles. No information regarding topic anaesthetic has been provided. No information regarding allergies has been provided. No information regarding medical history and presence of risk factors have been provided. On 07 feb 2022, same day of notification, qa department at prollenium medical technologies contacted clinic/injector requesting information regarding this clinical complaint, no response from the injector/clinic has been received. On 14 feb 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint, no response from the injector/clinic has been received. On 03 mar 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint, no response from the injector/clinic has been received. On 07 mar 2022, a sales representative informed the qa department at prollenium medical technologies that she will follow-up with the clinic regarding this adverse event again. The qa department at prollenium medical technologies will continue the investigation.
 
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Brand NameREVANESSE
Type of DeviceREVANESSE
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway n
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer Contact
ario khoshbin
138 industrial parkway n
aurora, on L4G 4-C3
CA   L4G 4C3
MDR Report Key13693827
MDR Text Key287007555
Report Number3004423487-2022-00008
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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